# FDA recall Z-2260-2019

> **Degania Silicone, Ltd.** · Class II · device recall initiated 2019-06-28.

## Product

Cardinal Health Jackson-Pratt Channel  Drain 15FR    Cardinal PN:JP-2223     An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

## Reason for recall

15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring  additional surgical intervention to remove the broken end from patient's body

## Distribution

Nationwide Distribution

## Key facts

- **Recall number:** Z-2260-2019
- **Recalling firm:** Degania Silicone, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-28
- **Report date:** 2019-08-21
- **Termination date:** 2020-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dganya Bet, N/A, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2260-2019

## Citation

> AI Analytics. FDA recall Z-2260-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2260-2019. Source: US FDA. Licensed CC0.

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